Multi-Center Efficacy Study of the GelStix™, 2016

Multi-Center Efficacy Study of the GelStix™ Nucleus Augmentation Device to treat Chronic Discogenic Low Back Pain
March 10, 2016

The Swiss Ethics Committee approved a randomized, double-blind, placebo controlled, multi-center efficacy study of the GelStix™ Nucleus Augmentation Device to treat chronic discogenic low back pain.

Degenerative Disc Disease (DDD) is one of the most common spinal pathologies, affecting up to 10-15 % of adults. The degeneration is associated with diminished water-binding capabilities of the nucleus pulpous leading to disc dehydration, volume reduction, changes in cellular activity, biomechanical changes and painful symptoms. Patients are initially treated with non-surgical pain-management techniques, such as anti-inflammatory medications and physical therapy, but these therapies often provide only temporary relief. When non-surgical intervention fails, fusion or total disc arthroplasty are often prescribed, both of which are highly invasive surgeries with significant associated morbidity. The purpose of this study is to evaluate the efficacy of treatment with the GelStix™ device in a patient population that had no benefit from conservative care.

The GelStix™ Nucleus Augmentation Device provides a ground-breaking approach for treating lower back pain associated with DDD and aging. It is shaped in the form of an elongated matchstick that is inserted under local anesthesia through an 18-gauge needle. The GelStix™ Nucleus Augmentation hydrates through the absorption of the body’s own fluids and acts as a reservoir of permanent hydration, producing increased pressure, improved fluid exchange, and pH balance and, thus, restoring the disc to a healthy state.